In many fields of technology, in particular fields in which use of specific technical devices is regulated by law, it is necessary to create complex documentation comprising information about the conditions to which the respective technical device has been tested. Only with such documentation, compliance with legal provisions for selling and using the device is possible. However, the device to be tested may often be described as a system having a complex and detailed structure comprising a number of components. Testing the whole system for example as to operational safety often appears to be complicated and cumbersome, in particular in the event that a new test is necessitated by changing only part of the system or a test procedure.
US 2009/0094061 A1 discloses to generate medical documentation sets by replicating a predetermined medical template and associating a unique medical label with the medical documentation in order to meet statutory requirements. The aim of this publication is to electronically document medical care performed on a specific patient.
US 2006/0271393 A1 discloses a computer system for rapid design of multiple component products, especially medical products, comprising a qualification and validation processing and an audit processing which are designed to meet the requirements mandated by the US food and drug administration (FDA). The system is configured to take into account information provided by a customer.
US 2008/0115114 A1 teaches to discover the functional aspects of a piece of software code using a system which includes a unit testing application which is designed to automate the unit testing of the subject software code. The system is configured to generate reports about the testing, which merely comprise information about a testing result but do not include any information about the testing procedure itself.
U.S. Pat. No. 7,533,369 B2 discloses a system and method for generating software documentation having a testing module which includes an automated documentation generation module. The system and method are configured to automatically generate documentation and user training materials following any changes applied to the software during development.
U.S. Pat. No. 7,490,319 B2 discloses a testing tool for testing of complex software systems having a plurality of interrelated system components and a suite of test scenarios for testing the performance of the plurality of interrelated system components. The testing tool includes a means for executing all or a subset of the test scenarios associated with the interrelated system components, and a means for evaluating the results of the executed test scenarios. The aim of that disclosure also is to enable auditing of changes, in particular generating documentation, and to ensure compliance with internal or regulatory requirements. A graphical display is provided for displaying parent-child relationships between individual test cases at a plurality of levels and for indicating which test cases or software module may be affected by changes in a single test case or software module. It, however, appears that the entire software system is re-tested after one or more of its modules has been changed.